FDA 510(k)Livewire 電生理學導管
K 號：K151617 · 2016-01-22
決定日期2016-01-22
產品代碼NLH
諮詢委員會履歷
決定相當於
器材摘要
Livewire Electrophysiology Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings Inc.(Dba Medline Ren. It received FDA 510(k) clearance on 2016-01-22 under 510(k) number K151617. The device is classified under product code NLH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Livewire Electrophysiology Catheter?
Livewire Electrophysiology Catheter is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is Surgical Instrument Service and Savings Inc.(Dba Medline Ren. The 510(k) number is K151617.
When did Livewire Electrophysiology Catheter receive FDA 510(k) clearance?
Livewire Electrophysiology Catheter received FDA 510(k) clearance on 2016-01-22, under 510(k) number K151617.
Who is the listed applicant for Livewire Electrophysiology Catheter?
The FDA 510(k) record lists Surgical Instrument Service and Savings Inc.(Dba Medline Ren as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Livewire Electrophysiology Catheter?
The FDA product code for Livewire Electrophysiology Catheter is NLH.
相關臨床試驗
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
其他以 Surgical Instrument Service and Savings Inc.(Dba Medline Ren 為申請人之記錄
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
相關器械（代碼：NLH）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
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